Government Updates

The resources and materials in this section are aimed at providing updates on public policy issues that have the potential to impact your advocacy work and the patients you serve.

New FDA will ‘enhance patient perspective in drug development’

New FDA will ‘enhance patient perspective in drug development’

The Federal Drug Agency (FDA) is developing tools to help incorporate the ...
FDA’s partnership approach to tackling health disparity

FDA’s partnership approach to tackling health disparity

Ensuring minorities are represented in clinical trials and sharing cultural ...
FDA to incorporate more digital technology in healthcare practices

FDA to incorporate more digital technology in healthcare practices

The Food and Drug Administration (FDA) has launched new plans to incorporat ...
New FDA triage website will improve dialogue with patient advocacy groups

New FDA triage website will improve dialogue with patient advocacy groups

The Food and Drug Administration’s (FDA) Center for Drug Evaluation and R ...
What’s next for the FDA and patient-focused drug development?

What’s next for the FDA and patient-focused drug development?

The Food and Drug Administration (FDA) is to focus on giving guidance for h ...
Paving the way for patient focused drug development

Paving the way for patient focused drug development

The U.S. Food and Drug Administration (FDA) has delivered a welcome message ...
Changing the value conversation in healthcare

Changing the value conversation in healthcare

In a bid to redefine value from the patient perspective, new guidelines for ...
Empowering patients with the tools to better understand the prescription process

Empowering patients with the tools to better understand the prescription process

Established in 2006, the Alliance for Patient Access (AfPA) is a national n ...
FDA considering

FDA considering “Office of Patient Affairs” to help integrate patient voice into medical product regulation

The Food and Drug Administration (FDA) is considering the creation of an &# ...
Newly passed New York Step Therapy Bill will bring better access to critical rare disease medicines

Newly passed New York Step Therapy Bill will bring better access to critical rare disease medicines

On Dec. 30, bill S.3419C/A.2834D – also known as the “New York Step The ...
Why it’s critical to ask the right questions during the next phase of health reform

Why it’s critical to ask the right questions during the next phase of health reform

With Members of Congress back at work this week, it’s clear that healthca ...
The era of patient-centered medicine at FDA

The era of patient-centered medicine at FDA

In recent years the U.S. Food and Drug Administration (FDA) has endeavored ...
Astellas Statement on 21st Century Cures Act

Astellas Statement on 21st Century Cures Act

Astellas applauds Congress’ passage of the 21st Century Cures Act. We bel ...
Astellas engages with organ transplant patients to better address their needs at patient-focused FDA meeting

Astellas engages with organ transplant patients to better address their needs at patient-focused FDA meeting

Astellas’ commitment to improving patient lives was exemplified at the 20 ...
Astellas scientist Anne Keating writes about her visit to Capitol Hill and the promise of science

Astellas scientist Anne Keating writes about her visit to Capitol Hill and the promise of science

Last month, Anne Keating, Pharm.D., Vice President of Clinical Science Onco ...
National Health Council develops value model get-ready checklist for patient organizations

National Health Council develops value model get-ready checklist for patient organizations

With ever-increasing weight placed on the value of healthcare treatments an ...
Jim Robinson highlights excitement and promise of medical innovation in Forbes.com

Jim Robinson highlights excitement and promise of medical innovation in Forbes.com

As leaders across healthcare work together to maximize the promise of medic ...
PDUFA VI goals letter released

PDUFA VI goals letter released

On Friday,  July 15, the Food and Drug Administration published the perfor ...
Pennsylvania and Alaska governors sign oral chemo parity laws

Pennsylvania and Alaska governors sign oral chemo parity laws

This week, Alaska and Pennsylvania became the 41st and 42nd states in the U ...
Looking ahead in the states in 2016

Looking ahead in the states in 2016

Elections, budget woes and health care discourse are expected to drive a fu ...
Tapping real-world evidence to achieve better value in healthcare

Tapping real-world evidence to achieve better value in healthcare

There’s a common saying – “you’re only as good as your data.” In ...
From volume to value - designing a patient-centered health care system

From volume to value – designing a patient-centered health care system

Health care delivery and payment have come a long way… but are they truly ...
Forging a path to outcomes-based high-quality patient care

Forging a path to outcomes-based high-quality patient care

The way we view and work in the health care economy is changing dramaticall ...